The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)
3 other identifiers
interventional
1,755
46 countries
493
Brief Summary
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
Typical duration for phase_3
493 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedStudy Start
First participant enrolled
June 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 12, 2028
April 15, 2026
April 1, 2026
3.3 years
March 7, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76
up to 76 weeks
Secondary Outcomes (6)
Time to first adjudicated pulmonary exacerbation up to Week 76
up to 76 weeks
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) respiratory symptoms domain score at Week 52 (participants ≥ 16 years)
at baseline, at week 52
Absolute change from baseline in post-bronchodilator Forced Expiratory Volume in the first second (FEV1) %pred at Week 52
at baseline, at week 52
Absolute change from baseline in post-bronchodilator Forced Vital Capacity (FVC) %pred at Week 52
at baseline, at week 52
Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76
up to 76 weeks
- +1 more secondary outcomes
Study Arms (2)
Treatment arm
EXPERIMENTALPlacebo arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information.
- Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
- Age of participants when signing the informed consent/assent ≥12 years.
- \-- Adolescents need to weigh at least 35 kg at Visit 1.
- Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.
- Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.
- Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
- History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:
- at least 2 exacerbations, or
- at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 (adults only)
- at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.
You may not qualify if:
- Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
- Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
- Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
- Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
- Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
- Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
- estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \<30 mL/min at Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (495)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Providence Medical Group Alaska
Anchorage, Alaska, 99508, United States
Dignity Health, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of Arizona
Tucson, Arizona, 85724, United States
Newport Native MD, Inc
Newport Beach, California, 92663, United States
Paradigm Clinical Research - Redding
Redding, California, 96001, United States
University of California Davis
Sacramento, California, 95817, United States
University of California San Francisco
San Francisco, California, 94143, United States
Ventura County Medical Center
Ventura, California, 93003, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine
North Haven, Connecticut, 06473, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Central Florida Pulmonary Group
Altamonte Springs, Florida, 32701, United States
Meris Clinical Research-Brandon-69466
Brandon, Florida, 33511, United States
St. Francis Medical Institute
Clearwater, Florida, 33765, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
University of Florida College of Medicine
Jacksonville, Florida, 32209, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
Essence MD Research
Naples, Florida, 34102, United States
Premier Medical Associates
The Villages, Florida, 32159, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30342, United States
Augusta University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine
Towson, Maryland, 21286, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55902, United States
Health Partners Specialty
Saint Paul, Minnesota, 55130, United States
University Of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1230, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
New York Medical College - Hawthorne
Hawthorne, New York, 10532, United States
Northwell Health
New Hyde Park, New York, 11040, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Stern Research Partners, LLC
Huntersville, North Carolina, 28078, United States
Pinehurst Medical Clinic, Inc. - East
Pinehurst, North Carolina, 28374, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
ProMedica Physicians Pulmonary and Sleep Medicine - Toledo
Toledo, Ohio, 43606, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, United States
Horizon Clinical Research Group
Cypress, Texas, 77429, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
El Paso Pulmonary Association
El Paso, Texas, 79902, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Metroplex Pulmonary & Sleep Center
McKinney, Texas, 75069, United States
Methodist Heart and Lung Institute
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Element Research Group
San Antonio, Texas, 78258, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Intermountain Healthcare
Murray, Utah, 84107, United States
University of Vermont
Burlington, Vermont, 05401, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University Health Systems
Richmond, Virginia, 23219, United States
University of Washington
Seattle, Washington, 98195, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Centro Dr. Lazaro Langer S.R.L
Alberdi Sur, X5003DCE, Argentina
CEC- Centro de Especialidades Cardiovasculares
Bahía Blanca, Argentina
Hospital Aleman
CABA, 1118, Argentina
Centro de Investigación Clinica Belgrano
CABA, 1425, Argentina
CEDIC - Centro de Investigacion Clinica
CABA, C1060ABN, Argentina
Mautalen- Salud e Investigacion
CABA, C1128AAF, Argentina
Equipo Ciencia
CABA, C1428BNF, Argentina
APRILLUS-Asistencia e Investigacion
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, 7600, Argentina
Centro Respiratorio de Quilmes
Quilmes, B1878FNR, Argentina
Instituto de Especialidades de la Salud Rosario
Rosario, 2000, Argentina
Ibamedica
Santa Fe, 3000, Argentina
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Macquarie University
North Ryde, New South Wales, 2109, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Heart of Australia Research Institute
Chelmer, Queensland, 4068, Australia
Lung Research Queensland
Chermside, Queensland, 4032, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Peninsula Health
Frankston, Victoria, 3199, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Institute for Respiratory Health
Nedlands, Western Australia, 6009, Australia
Trialswest
Spearwood, Western Australia, 6163, Australia
Medical University Graz
Graz, 8036, Austria
Medical University of Innsbruck
Innsbruck, 6020, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Vitaz - Campus Sint-Niklaas
Sint-Niklaas, 9100, Belgium
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240, Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, 18618-687, Brazil
Chronos Pesquisa Clinica
Brasília, 72145-450, Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, 74605-020, Brazil
Mecas Servicos Educacionais e Administrativos LTDA
João Pessoa, 58042-040, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074, Brazil
Netspiro Clinica Medica Ltda - Respsono
São Bernardo do Campo, 09750-420, Brazil
INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo, 05403-000, Brazil
MHAT Rahila Angelova AD
Pernik, 2300, Bulgaria
Medical Center Unimed
Plovdiv, 4023, Bulgaria
SHATPPD "Dr. Dimitar Gramatikov"
Rousse, 7002, Bulgaria
Multiprofile Hospital MHATEM 'Pirogov', Sofia
Sofia, 1606, Bulgaria
Diagnostics And Consultation Center Convex Ltd.
Sofia, 1680, Bulgaria
Diagnostics And Consultation Center Convex Ltd.
Sofia, 1680, Bulgaria
Medical Center "Pulmovision"
Sofia, 1756, Bulgaria
Medical Center Tara
Veliko Tarnovo, 5000, Bulgaria
Medical Center "Sveti Ivan Rilski"
Vidin, 3700, Bulgaria
Sbalpfz-Vratsa
Vratsa, 3001, Bulgaria
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V6Z 1Y6, Canada
Cardio 1 Medical Clinic
Winnipeg, Manitoba, R3L 1Z5, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
BLC Clinical Research
Burlington, Ontario, L7N 3V2, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, J1E 0N8, Canada
Diex Recherche (Trois-Rivieres)
Trois-Rivières, Quebec, G9A 4P3, Canada
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan, S7N 0W8, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5, Canada
Centro de Estudios Clínicos CEC
Santiago, 7750000, Chile
Centro de Investigación del Maule
Talca, 3465586, Chile
China-Japan Friendship Hospital
Beijing, 100029, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Children's Hospital, Capital Medical University
Beijing, 100045, China
Peking University Third Hospital
Beijing, 100191, China
Peking Union Medical College Hospital
Beijing, 100730, China
The First Hospital of Jilin University
Changchun, 130000, China
The Second Hospital of Jilin University
Changchun, 130000, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
West China Hospital, Sichuan University
Chengdu, 610041, China
People's Hospital of Sichuan Province
Chengdu, 610072, China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510000, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
Guizhou People's Hospital
Guiyang, 550002, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Hangzhou First People's Hospital
Hangzhou, 310006, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Zhejiang Hospital
Hangzhou, 310013, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huzhou Central Hospital
Huzhou, 313000, China
Jiangmen Central Hospital
Jiangmen, 529030, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
Nanjing First Hospital
Nanjing, 210006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
Ningbo Medical Center Lihuili Hospital
Ningbo, 315000, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Pingxiang People's Hospital
Pingxiang, 337000, China
Qingdao Municipal Hospital
Qingdao, 266011, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, 362000, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032, China
Huadong Hospital affiliated to Fudan University
Shanghai, 200040, China
Tongji Hospital, Tongji University
Shanghai, 200065, China
Shanghai General Hospital
Shanghai, 200080, China
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, 200240, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
The Children's Hospital of Fudan University
Shanghai, 201102, China
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
Shanghai, 201700, China
Shenzhen People's Hospital
Shenzhen, 518020, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University General Hospital
Tianjin, 30052, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wenzhou People's Hospital
Wenzhou, 325006, China
Wuhan Union Hospital
Wuhan, 430056, China
Wuxi People's Hospital
Wuxi, 214043, China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061, China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221006, China
Northern Jiangsu People's Hospital
Yangzhou, 225001, China
Yixing People'S Hospital
Yixing, 214258, China
Clinical Hospital Centar Sestre Milosrdnice
Zagreb, 10000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
MediTrial s.r.o.
Jindřichův Hradec, 377 01, Czechia
University Hospital Motol
Prague, 15000, Czechia
The First Pulmonary Private Practice
Prague, 19000, Czechia
Aalborg Sygehus Syd
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100, Denmark
Vejle University Hospital
Vejle, 7100, Denmark
CRC-Alexandria University
Alexandria, Egypt
Ain Shams University Clinical Research Center (MASRI)
Cairo, 11566, Egypt
Air Force Specialized Hospital
Cairo, 11835, Egypt
Kasr Al Aini, Cairo University
Cairo, 11956, Egypt
Helsinki University Hospital
Helsinki, 00290, Finland
Oulun yliopistollinen keskussairaala
Oulu, 90220, Finland
Tampere University Hospital
Tampere, 33520, Finland
Turku University Hospital / TYKS
Turku, 20521, Finland
CHU Amiens-Picardie
Amiens, 80054, France
HOP Intercommunal
Créteil, 94000, France
INS Coeur Poumon
Lille, 59037, France
Hopital De La Croix-Rousse
Lyon, 69004, France
HOP Arnaud de Villeneuve
Montpellier, 34295, France
Hôpital Pasteur
Nice, 06001, France
Hôpital Cochin
Paris, 75014, France
HOP Haut-Lévêque
Pessac, 33604, France
HOP Pontchaillou
Rennes, 35000, France
HOP Nord Laennec
Saint-Herblain, 44800, France
Hôpital Larrey - CHU de Toulouse
Tououse, 31059, France
Universitätsklinikum Aachen, AöR
Aachen, 52074, Germany
Velocity Clinical Research Germany GmbH, Ahrensburg
Ahrensburg, 22926, Germany
CIMS Studienzentrum Bamberg GmbH
Bamberg, 96049, Germany
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Katholisches Klinikum Bochum gGmbH
Bochum, 44791, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Augustiner Krankenhäuser GmbH
Cologne, 50678, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Caritas-Krankenhaus St. Maria gGmbH
Donaustauf, 93093, Germany
Klinikum Dortmund gGmbH
Dortmund, 44145, Germany
Technische Universität Dresden
Dresden, 01307, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131, Germany
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, 06120, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, 06120, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Klinikum der Universität München AÖR
München, 80336, Germany
Pneumologisches Studienzentrum München-West
München, 81241, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
Helios Hanseklinikum Stralsund
Stralstund, 18435, Germany
BAG Wiesbaden
Wiesbaden, 65183, Germany
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Koranyi National Institute For Pulmonolgy
Budapest, 1028, Hungary
BKS Research Ltd
Hatvan, H-3000, Hungary
Da Vinci Private Clinic
Pécs, 7635, Hungary
Jawahar Lal Nehru Medical College
Ajmer, 305001, India
M. S. Ramaiah Institute of Health Science
Bengaluru, 560054, India
Narayana Health - Mazumdar Shaw Medical Center
Bengaluru, 560099, India
B. P. Poddar Hospital and Medical Research Limited
Kolkata, 700053, India
Midland Healthcare & Research Center
Lucknow, 226006, India
Siddhi Hospital, C/o Dr. Mutha Hospital
Nashik, 422007, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001, India
Government Hospital for Chest and Communicable Diseases (GHCCD)
Visakhapatnam, 530017, India
Cork University Hospital
Cork, T12 DC4A, Ireland
St. Vincent's University Hospital
Dublin, D04 T6F4, Ireland
Connolly Hospital Blanchardstown
Dublin, D15 X40D, Ireland
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, 9112001, Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, 9765422, Israel
Rabin Medical Center Beilinson
Petah Tikva, 4941492, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126, Italy
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, 95121, Italy
Azienda Ospedaliera San Martino
Genova, 16132, Italy
Istituto G. Gaslini
Genova, 16147, Italy
A.O.U.Policlinico G.Martino
Messina, 98124, Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Socio Sanitaria Territoriale Di Monza
Monza (MB), 20900, Italy
A.O. dei Colli
Naples, 80131, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128, Italy
Policlinico "Paolo Giaccone"
Palermo, 90127, Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
Osp. Pediatrico Bambin Gesù
Roma, 00165, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Nagoya University Hospital
Aichi, Nagoya, 466-8560, Japan
Hirosaki University Hospital
Aomori, Hirosaki, 036-8563, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
Kameda Clinic
Chiba, Kamogawa, 296-0041, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Fukuoka Children's Hospital
Fukuoka, Fukuoka, 813-0017, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Aso Co.,Ltd Iizuka Hospital
Fukuoka, Iizuka, 820-8505, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Terada Clinic, Respiratory Medicine & General practice
Hyogo, Himeji, 670-0849, Japan
University of Tsukuba Hospital
Ibaraki, Tsukuba, 305-8576, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima, 890-8520, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051, Japan
Minami Kyoto Hospital
Kyoto, Joyo, 610-0113, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Matsusaka City Hospital
Mie, Matsusaka, 515-8544, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Oita University Hospital
Oita, Yufu, 879-5593, Japan
Kurashiki Central Hospital
Okayama, Kurashiki, 710-8602, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, Japan
Osaka Toneyama Medical Center
Osaka, Toyonaka, 560-8552, Japan
Saga University Hospital
Saga, Saga, 849-8501, Japan
Saitama Cardiovascular and Respiratory Center
Saitama, Kumagaya, 360-0197, Japan
Shiga University of Medical Science Hospital
Shiga, Otsu, 520-2192, Japan
Matsue Medical Center
Shimane, Matsue, 690-8556, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
Tenryu Hospital
Shizuoka, Hamamatsu, 434-8511, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610, Japan
Fukujuji Hospital
Tokyo, Kiyose, 204-8522, Japan
Toranomon Hospital
Tokyo, Minato-ku, 105-8470, Japan
National Center for Child Health and Development
Tokyo, Setagaya-ku, 157-8535, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582, Japan
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666, Japan
Yamaguchi University Hospital
Yamaguchi, Ube, 755-8505, Japan
Multidisciplinary City Hospital №1 of the Akimat of Astana
Astana, 010000, Kazakhstan
Regional Clinical Hospital of the Health Department of the Karaganda Region
Karaganda, 100019, Kazakhstan
Med.Center OLVI Health Center Assotiation,Private Practice
Daugavpils, 5410, Latvia
Daugavpils Regional Hospital LTD Centre Outpatient Clinic
Daugavpils, 5417, Latvia
VCA Dubultu Medical center
Jūrmala, 2015, Latvia
Riga 1st Hospital
Riga, 1001, Latvia
LUMPII Doctors practice
Riga, 1011, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV-1002, Latvia
Riga East University Hospital
Upeslejas, 2118, Latvia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50161, Lithuania
Republic Klaipeda Hospital
Klaipėda, 92231, Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, 08661, Lithuania
Hospital Sultanah Bahiyah
Alor Setar, Kedah, 05460, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, 43000, Malaysia
Hospital Raja Perempuan Zainab II
Kelantan, 15586, Malaysia
Institut Perubatan Respiratori
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203, Mexico
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, 31203, Mexico
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160, Mexico
Soluciones terapeuticas medico quirurgicas S de RL de CV
Mexico City, 03650, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, 64460, Mexico
Oaxaca Site Management Organization, S.C.
Oaxaca City, 68000, Mexico
Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)
Pachuca, 42070, Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055, Mexico
Arke SMO S.A. de C.V.
Veracruz de Ignacio de La Llave, 91900, Mexico
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD, Netherlands
Amsterdam UMC Locatie VUMC
Amsterdam, 1081HV, Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015 GD, Netherlands
Haga Ziekenhuis
The Hague, 2545 AA, Netherlands
UMC Utrecht
Utrecht, Netherlands
Gelre Ziekenhuis Zutphen
Zutphen, 7207 AE, Netherlands
NZ Respiratory and Sleep Institute
Greenlane East, Auckland, 1051, New Zealand
Momentum clinical Research Tauranga
Tauranga, Bay of Plenty, 3110, New Zealand
Momentum Clinical Research Dunedin
Dunedin, Otago, 9016, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 3240, New Zealand
Momentum Clinical Research
Mount Cook, Wellington Region, 6021, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Middlemore Clinical Trials
Papatoetoe, 2025, New Zealand
Iloilo Doctors Hospital
Iloilo City, 5000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
Health Cube Medical Clinics
Mandaluyong, 1552, Philippines
Quirino Memorial Medical Center
Quezon City, 1109, Philippines
Philippine General Hospital
Taft, Manila, 1000, Philippines
Respiratory Medicine Centre, private prac., Bialystok
Bialystok, 15044, Poland
M2M Med Sp. z o.o.
Chorzów, 41-500, Poland
Screenmed Sp. z o.o.
Piaseczno, 05500, Poland
EMED, Center of Medical Services,Private Prac,Rzeszow
Rzeszów, 35205, Poland
Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
Warsaw, 01-456, Poland
Medical Center K2J2
Wołomin, 05200, Poland
ULS da Região de Aveiro
Aveiro, 3814-501, Portugal
ULS Braga
Braga, 4710-243, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3004-561, Portugal
ULS do Alto Ave
Guimarães, 4835-045, Portugal
ULS da Região de Leiria, E.P.E.
Leiria, 2410-197, Portugal
ULS de Santa Maria, E.P.E
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4202-451, Portugal
San Juan Bautista School of Medicine
Caguas, 00726, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
Puerto Rico Consortium for Clinical Investigation
San Juan, 00927, Puerto Rico
Marius Nasta Institute of Pneumophthisiology
Bucharest, 050159, Romania
SC Medlife S.A
Cluj-Napoca, 400001, Romania
Clinical Hospital of Pneumophysiology Leon Daniello
Cluj-Napoca, 400371, Romania
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Timișoara, 300310, Romania
National University Hospital-Singapore-42005
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Univ. Hospital Martin
Martin, 036 01, Slovakia
Plucna ambulancia Hrebenar s.r.o.
Spišská Nová Ves, 05201, Slovakia
Iatros International
Bloemfontein, 9301, South Africa
Dr Ismail Abdullah
Cape Town, 7764, South Africa
Addington Hospital
Durban, 4001, South Africa
Enhancing Care Foundation NPC
Mount Edgecombe, 4301, South Africa
CAPRISA Offices on the King DinuZulu Hospital Complex
Springfield, 4091, South Africa
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
Chungbuk National University Hospital
Chungju, 28644, South Korea
Yeongnam University Hospital
Daegu, 42415, South Korea
Ulsan University Hospital
Dong-gu Ulsan, 44033, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
Severance Hospital
Seoul, 03722, South Korea
Hanyang University Medical Center
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Kangdong Sacred Heart Hospital
Seoul, 05355, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07071, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 22711, South Korea
Jeonbuk National University Hospital
Seoul, 54907, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Hospital Infanta Elena
Huelva, 21080, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, 11407, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital de Mérida
Mérida, 06800, Spain
Hospital Central de Asturias
Oviedo, 33011, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitario Puerto Real
Puerto Real, 11510, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026, Spain
Universitetssjukhuset, Örebro
Örebro, 703 62, Sweden
Karolinska University Hospital
Stockholm, SE-171 64, Sweden
CTC Clinical Trial Consultants AB
Uppsala, 751 85, Sweden
Universitätsspital Basel
Basel, 4031, Switzerland
University Hospital of Lausanne
Lausanne, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 333, Taiwan
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, 632, Taiwan
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
King Chulalongkorn Memorial Hospital
Thailand, 10330, Thailand
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 06018, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06620, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, 07070, Turkey (Türkiye)
Adnan Menderes Üniversitesi
Aydin, 09100, Turkey (Türkiye)
Istanbul University Medical Faculty Capa Hospital
Istanbul, 34093, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, 34890, Turkey (Türkiye)
Manisa Celal Bayar Üniversitesi Tıp Fakültesi
Manisa, 45030, Turkey (Türkiye)
Mersin University Research and Training Hospital Chest Diseases Department
Yenişehir, 33110, Turkey (Türkiye)
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Velocity Clinical Research, Bristol
Bristol, BS8 2RA, United Kingdom
Royal Papworth Hospital
Cambridge, CB2 0AY, United Kingdom
University Hospital Llandough
Cardiff, CF64 2XX, United Kingdom
Ninewells Hospital & Medical School
Dundee, Scotland, DD1 9SY, United Kingdom
University Hospital Hairmyres
East Kilbride, G75 8RG, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Royal Hospital for Children and Young People
Edinburgh, EH16 4TJ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Freeman Hospital
High Heaton, NE7 7DN, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, L14 3PE, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Craigavon Area Hospital
Portadown, BT63 5QQ, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2025
First Posted
March 12, 2025
Study Start
June 9, 2025
Primary Completion (Estimated)
September 14, 2028
Study Completion (Estimated)
October 12, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.